Note: Javascript is disabled or is not supported by your browser. For this reason, some items on this page will be unavailable. For more information about this message, please visit this page: About CDC.gov.

Warning:

This online archive of the CDC Prevention Guidelines Database
is being maintained for historical purposes, and has had no new entries
since October 1998. To find more recent guidelines, please visit the following:

Evaluation of Safety Devices for Preventing Percutaneous Injuries
Among Health-Care Workers During Phlebotomy Procedures --
Minneapolis-St. Paul, New York City, and San Francisco, 1993-1995

MMWR 46(02);21-25

Publication date: 01/17/1997

Table of Contents

Article

Health-care workers (HCWs) are at risk for infections with
bloodborne pathogens resulting from occupational exposures to blood
through percutaneous injuries (PIs). Phlebotomy, one of the most
commonly performed medical procedures, has been associated with
13%-62% of injuries reported to hospital occupational health
services (1,2) and with 20 (39%) of the 51 documented episodes of
occupationally acquired human immunodeficiency virus (HIV)
infection reported in the United States (CDC, unpublished data,
1996). Although safety devices designed to prevent PIs associated
with phlebotomy have been available for use in the United States,
clinical evaluation of these devices has been difficult because 1)
ascertainment of PIs is difficult (many injuries are unreported
{2,3}, and observation of all procedures is impractical because
phlebotomy is performed throughout the hospital by different groups
of HCWs at all hours), 2) data to calculate PI rates (i.e., the
number of phlebotomies performed and devices used) are not
routinely available, 3) a large number of phlebotomies must be
evaluated because of the low rates of phlebotomy-related PI, and 4)
rates of safety-feature activation are difficult to assess. This
report summarizes a collaborative study by CDC and six hospitals to
evaluate safety devices for phlebotomy. The findings indicate that
use of safety devices significantly reduced phlebotomy-related PI
rates while having minimal clinically apparent adverse effects on
patient care. *

The study was conducted in two phases during 1993-1995 at six
university-affiliated hospitals in Minneapolis-St. Paul, Minnesota
(three hospitals), New York, New York (one hospital), and San
Francisco, California (two hospitals). Each hospital selected the
products to be evaluated (vacuum-tube blood-collection devices
and/or winged steel needles with safety features). The assessment
was restricted to a comparison of safety devices with conventional
devices, not with other safety devices. Products evaluated included
a resheathable winged steel needle (Safety-Lok{trademark} {Becton
Dickinson, Franklin Lakes, New Jersey} ** {six hospitals}); a
bluntable vacuum-tube blood-collection needle activated while in
the patient's vein (Punctur-Guard{trademark} {Bio-Plexus, Inc.,
Tolland, Connecticut} {three hospitals}); and a vacuum-tube
blood-collection needle with a hinged recapping sheath
(Venipuncture Needle-Pro{trademark} {Smith Industries (Concord
Portex), Keene, New Hampshire} {four hospitals}). Each product
requires the HCW to activate the safety feature during or after
phlebotomy. Before introducing safety devices, each hospital
conducted a comprehensive training program for HCWs that included
"hands-on" experience with the equipment.

During phase I (mean duration among the hospitals: 10 months;
range: 9-12 months), hospitals used conventional phlebotomy devices
and conducted enhanced surveillance for injuries (e.g., encouraging
reporting, publishing notices in the hospital newsletter, posting
educational materials, and/or providing inservice training for
staff). An anonymous survey was distributed to four groups of HCWs
who routinely perform phlebotomies *** to estimate their rates of
underreporting of PIs to hospital surveillance systems and to
determine the average number of phlebotomies performed each day and
average number of days worked each week. The rates of PIs
associated with phlebotomy devices for HCWs in each of these four
groups were estimated by dividing the number of phlebotomy-related
PIs reported to the hospital's surveillance system during the study
period (adjusted for underreporting by occupation) by the total
number of phlebotomies performed (estimated from the daily average
number of phlebotomies performed by each HCW, the number of HCWs in
each of the four groups, and the duration of the study period).

During phase II (mean duration among the hospitals: 12 months;
range: 6-15 months), investigators replaced conventional phlebotomy
devices with safety devices hospitalwide, monitored supplies of
phlebotomy equipment to attempt to ensure that only safety devices
were available, continued enhanced surveillance for injuries, and
inventoried the autoclaved contents of a representative sample of
disposal containers for sharp instruments to determine rates of use
of safety devices and conventional devices and rates of activation
of safety features. The HCW survey was repeated 1-2 months before
the end of phase II, and the estimated PI rates for safety and
conventional devices were compared. The second HCW survey also
included questions to assess HCW satisfaction with safety devices
and to determine the occurrence of adverse effects in patients that
were apparent at the time of the phlebotomy ****.

The overall response rate for each of the two HCW surveys was
approximately 75%, based on estimates of the number of HCWs who
received survey forms; 1699 HCWs responded in phase I and 1421 in
phase II. Overall, respondents acknowledged reporting 302 (54%) of
563 needlestick injuries they had sustained from all types of
needles during the previous year. Reporting rates varied by
occupation: 91% of injuries among phlebotomists were reported, as
were 68% among nurses, 35% among medical students, and 31% among
residents. Within occupations, reporting rates were similar among
hospitals and between the two surveys. Because estimated rates of
phlebotomy-related PI by device and occupation were similar for
each hospital in which a particular device was used, data were
aggregated among hospitals to permit comparison of PI rates for
safety and conventional phlebotomy devices. Compared with
conventional devices, PI rates were lower for safety devices
(Table 1).

Of 41 PIs associated with safety devices, 34 (83%) involved
winged steel needles and seven (17%) involved vacuum-tube
blood-collection needles (Table 1). Twenty-five (61%) involved an
injury before activation of the safety feature was appropriate or
possible (e.g., within seconds after the device was removed from
the vein); six (15%) occurred during activation of the safety
feature (all with Safety-Lok{trademark}). For eight (20%), the
safety feature had not been activated, and for two (5%), the
mechanism of injury was unknown. Safety devices constituted 12,681
(89%) of the 14,261 phlebotomy devices in autoclaved
sharps-disposal containers. In the phase II HCW survey, HCWs were
asked "Do you prefer the safety device over conventional
equipment?" Among 1108 HCWs, 1879 responses were related to one or
more of the three devices; 822 (44%) responded yes; 622 (33%), no;
and 435 (23%), unsure.

Editorial Note

Editorial Note: The findings in this report suggest that safety
devices for phlebotomy can reduce the risk for occupational PIs
among HCWs. In particular, there was a significant reduction in
phlebotomy-related PIs associated with use of each of the
vacuum-tube blood-collection devices and a reduction in PIs
associated with use of the winged steel needles. Further decreases
in phlebotomy-related PIs might have been possible with increased
use of safety devices and/or increased activation of safety
features by HCWs. Experts have recommended that safety devices
include safety features that activate automatically and do not rely
on activation by HCWs (4,5). Although the assessment of potential
patient complications in this study was limited, short-term
complications were clinically minimal, and although patients were
not systematically monitored for long-term follow-up, phlebotomy
needles are not indwelling devices and long-term complications of
phlebotomy are rare.

Results of this study also suggest that safety devices for
phlebotomy may be generally acceptable to users. Activation rates
of safety features and user acceptability may be influenced by
factors such as the perceived risk for occupational infection by
the HCW, design of the device, training provided before and after
introduction of the device, length of time needed to become adept
at using the device, ease of use, necessary changes in technique,
and previous experience with safety devices (5). Further analyses
will assess whether safety-feature activation rates and user
acceptability in this study varied by hospital, city, occupation,
or device used. Acceptability of a device to an institution may be
influenced by cost.

In this study, only 54% of PIs were reported to hospital
surveillance systems -- a rate consistent with those documented in
previous studies (range: 5%-60% {2,3}). Failure to report PIs may
compromise appropriate postexposure management, including
postexposure prophylaxis for HIV and hepatitis B virus, and
assessment of occupational hazards and preventive interventions
(6,7). Health-care institutions and HCWs must further assess
reasons for underreporting and improve reporting of all
occupational blood exposures.

The Occupational Safety and Health Administration requires
that primary methods to reduce occupational PIs include engineering
controls (8), and the Food and Drug Administration has urged that
needleless or recessed needle systems be used to replace hypodermic
needles for accessing intravenous administration sets (9). Some
manufacturers are continuing efforts to develop and refine safety
devices to improve the effectiveness and acceptability of products.
The findings in this report and in a companion report evaluating
blunt suture needles (10) suggest that safety devices can be an
effective component in a needlestick-prevention program. The Public
Health Service is evaluating the implications of these and other
data in assessing the possible need for further guidance on
selection, implementation, and evaluation of safety devices in
health-care settings.

* Single copies of this report will be available free until January
16, 1998, from the CDC National AIDS Clearinghouse, P.O. Box 6003,
Rockville, MD 20849-6003; telephone (800) 458-5231 or (301)
217-0023.

** Use of trade names and commercial sources is for identification
only and does not imply endorsement by the Public Health Service or
the U.S. Department of Health and Human Services.

POINT OF CONTACT FOR THIS DOCUMENT:

To request a copy of this document or for questions concerning this
document, please contact the person or office listed below. If
requesting a document, please specify the complete name of the
document as well as the address to which you would like it mailed.
Note that if a name is listed with the address below, you may wish
to contact this person via CDC WONDER/PC e-mail.
For single issue purchase 800-843-6356
HOSPITAL INFECTIONS PROGRAM
State/Fed Gov: For free copies
write to: CDC, MMWR MS(C-08)
Atlanta, GA 30333